FDA Device recall Z-1902-2012
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat
- FDA Device
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of MULTIGENT Acetaminophen for use with Architect/Aeroset Cat by Sekisui Diagnostics, citing discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1902-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sekisui Diagnostics |
| Distribution | IL |
Product
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Reason
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Identifiers
| code_info | Lot 41928UQ11 {exp 2013-01 -31 ) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1902-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.